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A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management

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ClinicalTrials.gov Identifier: NCT02078492
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Brief Summary:
Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.

Condition or disease Intervention/treatment Phase
Pain Drug: 10 mg of Ketorolac Drug: 15 mg of Ketorolac Drug: 30 mg of Ketorolac Phase 4

Detailed Description:

Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is available in both oral and parenteral forms and possess significant analgesic potency. However, ketorolac provides few advantages over other currently available analgesics and its use is limited by a virtue of having an "analgesic ceiling" with the dose being 10mg as well as having a range of severe side effects, of which gastrointestinal hemorrhage is most concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not provide additional analgesia and do contribute to side effects. In spite of this, the majority of research conducted on ketorolac in the ED and recommendations in Tintinalli's Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages.

Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management in the Emergency Department"
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Group 1 - 10 mg of Ketorolac
Subjects will be administered 10 mg of Ketorolac for pain relief.
Drug: 10 mg of Ketorolac
Patients will receive 10 mg of Ketorolac for pain control.
Other Name: Toradol

Experimental: Group 2 - 15mg
Subjects will be administered 15mg of Ketorolac.
Drug: 15 mg of Ketorolac
Patients will receive 15mg of Ketorolac for pain control.
Other Name: Toradol

Experimental: Group 3 - 30mg
Subject will receive 30mg of Ketorolac as a part of standard care.
Drug: 30 mg of Ketorolac
Patients will receive 30mg of Ketorolac for pain control.
Other Name: Toradol




Primary Outcome Measures :
  1. Pain Score at 30 Minutes [ Time Frame: 30 minutes ]
    Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.


Secondary Outcome Measures :
  1. Adverse Effect of Dizziness [ Time Frame: 120 minutes ]
    the number of study patients who reported having dizziness after administration of medication.

  2. Adverse Effect of Nausea [ Time Frame: 120 minutes ]
    The number of study patients who reported nausea after administration of medication

  3. Adverse Effect of Headache [ Time Frame: 120 minutes ]
    The number of study patients who reported headache after administration of medication



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.

Exclusion Criteria:

Age >65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078492


Locations
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Antonios Likourezos
Investigators
Principal Investigator: Sergey Motov, MD Attending

Publications:
Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02078492     History of Changes
Other Study ID Numbers: 2014-01-19
First Posted: March 5, 2014    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action